Ignite Creation Date:
2024-05-05 @ 10:28 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01111526
Status:
COMPLETED
Last Update Posted:
2018-05-15
First Post:
2010-04-16
Brief Title:
Histone Deacetylase Inhibitor LBH589 in Addition to Corticosteroids in Patients With Acute Graft Versus Host Disease GVHD
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase III Trial Evaluating the Use of Histone Deacetylase Inhibitor LBH589 in Addition to Corticosteroids in Patients With Acute Graft Versus Host Disease
Status:
COMPLETED
Status Verified Date:
2016-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To test a new agent LBH589 in combination with glucocorticoids as initial therapy of acute graft versus host disease GVHD
Detailed Description:
Dose escalation study to test the safety Phase I pharmacology and preliminary clinical activity Phase II of a Novel histone deacetylase HDAC inhibitor LBH589 in the treatment of the following GVHD presentations Classic Late-onset acute GVHD Recurrent acute GVHD Overlap syndrome
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CLBH589BUS20T | OTHER | Novartis | None |